Suturing device provided with casing and depression formed in the same for receiving suturing target

ABSTRACT

In a suturing device, a casing has an elongated shape extending in a longitudinal direction. A needle is positioned in the casing, is configured to hold a first thread-like member, and has a tip end reciprocally moving along a path extending between a first position and a second position positioned backward than the first position in the longitudinal direction. A depression is formed in a peripheral wall of the casing, is positioned between the first and second positions in the longitudinal direction, and is configured to expose the needle to an outside of the casing. The shuttle includes a holding portion configured to hold a second thread-like member. The shuttle is configured to move within the casing at a third position between the first position and the depression in the longitudinal direction to change relative position between the second thread-like member and a loop formed in the first thread-like member.

CROSS REFERENCE TO RELATED APPLICATION

This application is a bypass continuation-in-part application ofInternational Application No. PCT/JP2017/029733 filed Aug. 21, 2017 inthe Japan Patent Office acting as Receiving Office, claiming priorityfrom Japanese Patent Application No. 2016-162285 filed Aug. 22, 2016.The entire contents of each of these applications are incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure relates to a suturing device that securesthread-like members together with each stitch and forms stitches orknots in the thread-like members.

BACKGROUND

Technologies have been proposed for forming a loop and a knot inthread-like members that have been passed through a suturing target andfor immobilizing the suturing target, including a technology that uses asuture anchor configured of metal or synthetic resin to clampthread-like members together (see U.S. Pat. No. 7,416,556), and atechnology for interlocking uneven formations pre-formed in thethread-like member itself (see U.S. Pat. No. 5,207,694). A technologyhas also been proposed for welding thread-like members together usingheat or ultrasound (see U.S. Pat. No. 5,417,700). However, thread-likemembers that are fixed by clamping together, interlocking, or weldingthe thread-like members have less binding strength and tighteningability than thread-like members that are tied together with a knot.

Accordingly, various methods of forming knots to secure thread-likemembers by tying the thread-like members themselves are well known, andvarious needle grasping devices, auxiliary tools, and the like forforming knots have been proposed.

One technology describes forming knots through an operation similar to amanual operation in which two grasping devices are simply manipulated tocontrol their positional relationship (see U.S. Pat. No. 5,336,230).This technology essentially requires that both grasping devices beoperated. Another device is an auxiliary suturing tool that forms knotsby performing a prescribed procedure (see U.S. Pat. No. 5,480,406). Thistechnology requires that another grasper be used for transferring thethread-like member, since a knot cannot be formed with the auxiliarysuturing tool alone.

SUMMARY

While various devices for tying thread-like members have been proposed,none of these devices is more than an auxiliary tool for aiding theoperator in tying the thread-like members and none successfully realizesa device for forming knots easily and reliably through mechanicaloperations.

With all of the above conventional devices, a human operator mustdetermine which side of what thread-like member to pass the grasper,when and where to grasp the thread-like member, how many times and inwhat direction to wrap the thread-like member, and the like and mustperform such operations based solely on information the operator takesin visually and the like. Accordingly, the operator must have hadsufficient training in advance and must have proficient technique inpractice in order to form knots using these tools. In other words, allof these tools require skill and cannot be defined as devices that canform knots reliably through simple mechanical operations.

In view of the foregoing, it is an object of the present disclosure toprovide a suturing device capable of easily and reliably formingstitches or knots through mechanical operations requiring only simplemanipulations.

In order to attain the above and other objects, the present disclosureprovides a suturing device that includes: a casing; a needle; adepression; and a shuttle. The casing has an elongated shape extendingin a longitudinal direction. The needle is positioned in the casing andhas an elongated shape extending in the longitudinal direction. Theneedle is configured to hold a first thread-like member and toreciprocally move forward and backward in the longitudinal direction toform a loop in the first thread-like member. The needle has a tip endreciprocally moving along a path extending between a first position anda second position in the longitudinal direction in the reciprocalmovement of the needle in the longitudinal direction. The first positionis positioned forward than the second position in the longitudinaldirection. The depression is formed in a peripheral wall of the casingand is positioned between the first position and the second position inthe longitudinal direction. The depression is configured to expose theneedle to an outside of the casing. The shuttle includes a holdingportion. The holding portion is configured to hold a second thread-likemember. The shuttle is configured to move within the casing at a thirdposition between the first position and the depression in thelongitudinal direction to change relative position between the secondthread-like member and the loop.

BRIEF DESCRIPTION OF THE DRAWINGS

The particular features and advantages of the disclosure as well asother objects will become apparent from the following description takenin connection with the accompanying drawings, in which:

FIG. 1 is a perspective view illustrating an entire exterior of asuturing device according to one embodiment of the present disclosure;

FIG. 2 is an enlarged perspective view illustrating a distal end portionof the suturing device according to the embodiment of the presentdisclosure;

FIG. 3 is a side view of the distal end portion of the suturing deviceillustrated in FIGS. 1 and 2;

FIG. 4 is an exploded perspective view illustrating each componentpositioned in a cylindrical member in the suturing device according tothe embodiment;

FIG. 5 is an exploded perspective view illustrating a shuttle guidemember to be inserted in the cylindrical member in the suturing deviceaccording to the embodiment;

FIG. 6 is a perspective view illustrating one example of a needle to beinserted in the cylindrical member in the suturing device according tothe embodiment;

FIG. 7 is an enlarged cross-sectional view of a needle guide grooveformed in a circumferential wall of the cylindrical member in thesuturing device according to the embodiment;

FIG. 8 is a perspective view illustrating another example of a needlehaving a shape different from the shape of the needle illustrated inFIG. 6;

FIG. 9 is a perspective view illustrating still another example of aneedle having a shape different from the shape of the needle illustratedin FIG. 6;

FIG. 10 is a view illustrating a distal end face of the cylindricalmember from which a semispherical cap is removed and a cross section ofthe shuttle guide member taken along a plane passing through a shuttleguide groove in the suturing device according to the embodiment;

FIG. 11 is a view corresponding to FIG. 10 and illustrating an initialstate of the suturing device according to the embodiment in which a loopis formed in a first thread-like member extending from a distal end ofthe needle of FIG. 6;

FIG. 12 is a view corresponding to FIG. 10 and illustrating a state ofthe suturing device according to the embodiment after a right-handrotating operation of approximately 70 degrees has been performed with afirst operating handle, whereby a first hook-shaped end of a shuttle haspassed through the loop;

FIG. 13 is a view corresponding to FIG. 10 and illustrating a state ofthe suturing device according to the embodiment after a right-handrotating operation of approximately 110 degrees has been performed withthe first operating handle, whereby a circumferential center portion ofthe shuttle has become positioned inside the loop;

FIG. 14 is a view corresponding to FIG. 10 and illustrating a state ofthe suturing device according to the embodiment after a right-handrotating operation of approximately 200 degrees has been performed withthe first operating handle, whereby the entire shuttle has passedthrough the loop and an end of a pusher has become positioned inside theloop;

FIG. 15 is a view corresponding to FIG. 10 and illustrating a state ofthe suturing device according to the embodiment after a left-handrotating operation of approximately 20 degrees has been performed withthe first operating handle from the position illustrated in FIG. 14,whereby both the shuttle and pusher are in positions rotated in 180degrees from the initial positions illustrated in FIG. 11;

FIG. 16 is a longitudinal cross-sectional view of a distal end portionof the suturing device according to the embodiment for describing aninsertion step in a single stitch forming operation with respect to abiological tissue;

FIG. 17 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing abiological tissue fixing step in the single stitch forming operationwith respect to the biological tissue;

FIG. 18 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing aneedle piercing step in the single stitch forming operation with respectto the biological tissue;

FIG. 19 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing a loopforming step in the single stitch forming operation with respect to thebiological tissue;

FIG. 20 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing a loopthreading step in the single stitch forming operation with respect tothe biological tissue;

FIG. 21 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing a looptightening step in the single stitch forming operation with respect tothe biological tissue;

FIG. 22 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing a hookadvancing step in the single stitch forming operation with respect tothe biological tissue;

FIG. 23 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing ahook-thread detaching step in the single stitch forming operation withrespect to the biological tissue;

FIG. 24 is a longitudinal cross-sectional view of the distal end portionof the suturing device according to the embodiment for describing athread hooking step in the single stitch forming operation with respectto the biological tissue;

FIG. 25 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, a hook member, and the needle for describing the insertion stepillustrated in FIG. 16 and the biological tissue fixing step illustratedin FIG. 17;

FIG. 26 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, the hook member, and the needle for describing the needlepiercing step illustrated in FIG. 18;

FIG. 27 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, the hook member, and the needle for describing the loop formingstep illustrated in FIG. 19;

FIG. 28 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, the hook member, and the needle for description of the loopthreading step illustrated in FIG. 20;

FIG. 29 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, the hook member, and the needle for description of the looptightening step illustrated in FIG. 21;

FIG. 30 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, the hook member, and the needle for description of the hookadvancing step illustrated in FIG. 22;

FIG. 31 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for description of the hook-thread detaching stepillustrated in FIG. 23;

FIG. 32 is a schematic view of the distal end portion of the suturingdevice according to the embodiment and particularly illustrating theshuttle, the hook member, and the needle for description of the threadhooking step illustrated in FIG. 24;

FIG. 33 is a timing diagram for describing timed-relational movements ofrespective components those involved in the single stitch formingoperation illustrated in FIGS. 16 through 24 and FIGS. 25 through 32 inthe suturing device according to the embodiment;

FIG. 34 is a schematic perspective view illustrating a state where aplurality of stitches is formed annularly in succession along an innercircumferential surface of a pouch-like biological tissue, using thesuturing device according to the embodiment;

FIG. 35 is a schematic perspective view illustrating a state where aknot is formed to prevent the stitches from unravelling after theplurality of stitches is formed over an entire circumference of theinner surface of the pouch-like biological tissue, using the suturingdevice according to the embodiment;

FIG. 36 is a schematic view illustrating a cross-section of thestructures illustrated in FIG. 35;

FIG. 37 is a developed view illustrating a state where the plurality ofstitches is formed annularly in succession along the innercircumferential surface of the pouch-like biological tissue and the knotis formed following the stitches with the first thread-like member and asecond thread-like member, using the suturing device according to theembodiment;

FIG. 38 is a schematic view of the cylindrical member of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for describing an insertion step in a half hitchforming operation;

FIG. 39 is a schematic view of the cylindrical member of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for describing a thread winding step in the halfhitch forming operation;

FIG. 40 is a schematic view of the cylindrical member of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for describing a needle advancing step in thehalf hitch forming operation;

FIG. 41 is a schematic view of the cylindrical member of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for describing a loop forming step in the halfhitch forming operation;

FIG. 42 is a schematic view of the cylindrical member of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for describing a loop threading step in the halfhitch forming operation;

FIG. 43 is a schematic view of the cylindrical member of the suturingdevice according to the embodiment and particularly illustrating theshuttle and the needle for describing a needle retracting step in thehalf hitch forming operation;

FIG. 44 is a schematic view illustrating a primitive form of a knotobtained by performing a half hitch forming operation at a first stageoperation and a half hitch forming operation at a second stage operationthe same as the first stage operation in accordance with the half hitchforming operation attendant to FIGS. 38 through 43;

FIG. 45 illustrates a granny knot produced by reshaping the primitivefrom of the knot illustrated in FIG. 44;

FIG. 46 is a timing diagram for describing timed-relational movements ofrespective components those involved in the half hitch forming operationillustrated in FIGS. 38 through 43 in the suturing device according tothe embodiment, and particularly illustrating an operation pattern A inwhich the needle exhibits a right-hand rotation for winding the firstthread-like member and the shuttle passed through the loop in the firstthread-like member while moving in a right-hand circumferentialdirection;

FIG. 47 is a timing diagram for describing timed-relational movements ofrespective components those involved in the half hitch forming operationillustrated in FIGS. 38 through 43 in the suturing device according tothe embodiment, and particularly illustrating an operation pattern B inwhich the needle exhibits a left-hand rotation for winding the firstthread-like member and the shuttle passed through the loop in the firstthread-like member while moving in a left-hand circumferentialdirection;

FIG. 48 is a schematic view illustrating a primitive form of a knotobtained by performing a half hitch forming operation at a first stageoperation and a half hitch forming operation at a second stage operationdifferent from the first stage operation in accordance with the halfhitch forming operation attendant to FIGS. 38 through 43;

FIG. 49 illustrates a square knot produced by reshaping the primitiveform of the knot illustrated in FIG. 48;

FIG. 50 is a table illustrating a relationship between the first stageoperation patterns and the second stage operation patterns and types ofproduced knots;

FIG. 51 illustrates a state where the second thread-like member held ina holding part of the shuttle has been passed through the loop formed inthe first thread-like member in the operation illustrated in FIGS. 38and 39; and

FIG. 52 is a schematic diagram illustrating that a loop defined by avirtual axis and the first thread-like member in which the loop isformed are projected onto a projecting plane orthogonal to the virtualaxis.

DETAILED DESCRIPTION

FIG. 1 is a perspective view illustrating an entire exterior of asuturing device 10 according to one embodiment of the presentdisclosure. FIG. 2 is an enlarged perspective view illustrating a distalend portion of the suturing device 10. FIG. 3 is a right side view ofthe distal end portion of the suturing device 10 illustrated in FIG. 2.FIGS. 4, 5, and 6 illustrate the various components of the suturingdevice 10 in various disassembled states. In the present embodiment, theupper portion of the suturing device 10 in FIG. 1 will be called thedistal end portion, and the bottom portion in FIG. 1 the proximal endportion.

The suturing device 10 has a long and hollow cylindrical member 12 thatis closed on the distal end. The cylindrical member 12 functions as acasing. The cylindrical member 12 is formed of two interconnectedcylindrical tubes 12 a and 12 b having an outer diameter of severalmillimeters, for example. A semispherical cap 14 is fitted onto thedistal end of the cylindrical member 12 (the cylindrical tube 12 a) forclosing the opening in the distal end. In use, the proximal end of thecylindrical member 12 is coupled to the distal end of a tubular couplingmember 16 that is flexible like a catheter, for example. The cylindricalmember 12 and the semispherical cap 14 fitted on the distal end of thecylindrical member 12 function as the casing of the suturing device 10.

The suturing device 10 is provided with a first operating shaft 20, asecond operating shaft 22, and a third operating shaft 24 that extendout from the proximal end of the cylindrical member 12 (the cylindricaltube 12 b). The first operating shaft 20, second operating shaft 22, andthird operating shaft 24 are flexible and serve to implement linearmoving operations along the longitudinal direction of the cylindricalmember 12 and rotating operations about respective axes.

The suturing device 10 is also provided with a first operating handle21, a second operating handle 23, and a third operating handle 25 thatare fixed to the proximal ends of the first operating shaft 20, secondoperating shaft 22, and third operating shaft 24, respectively. Thefirst operating shaft 20 is a shuttle operating shaft for operating ashuttle 26 provided in the cylindrical member 12. The first operatinghandle 21 fixed to the proximal end of the first operating shaft 20 isused to remotely control the linear position of the shuttle 26 in thelongitudinal direction of the cylindrical member 12 and the rotatedposition of the shuttle 26 about the axis of the first operating shaft20. The second operating shaft 22 is a needle operating shaft foroperating a needle 30 provided in the cylindrical member 12. The secondoperating handle 23 fixed to the proximal end of the second operatingshaft 22 is used to remotely control the linear position of the needle30 in the longitudinal direction of the cylindrical member 12 and therotated position of the needle 30 about the axis of the second operatingshaft 22. The third operating shaft 24 is a hook operating shaft thatoperates a hook member 28 provided in the cylindrical member 12. Thethird operating handle 25 fixed to the proximal end of the thirdoperating shaft 24 is used to remotely control the linear position ofthe hook member 28 in the longitudinal direction of the cylindricalmember 12 and the rotated position of the hook member 28 about the axisof the third operating shaft 24.

Arrows X in FIG. 1 illustrating rotating directions of the firstoperating handle 21, second operating handle 23, and third operatinghandle 25 indicate right-hand rotations. In the present embodimentdescribed below, the state of the suturing device 10 illustrated in FIG.1 will be considered a reference position, the side of s the suturingdevice 10 on the left diagonally near side of the drawing in FIG. 1 willbe called the front side, the side of the suturing device 10 on theright diagonally far side of the drawing in FIG. 1 will be called therear side. Further, the side of the suturing device 10 on the rightdiagonally near side of the drawing in FIG. 1 will be called the rightside, and the side of the suturing device 10 on the left diagonally farside of the drawing in FIG. 1 will be called the left side. Furthermore,the clockwise rotation of the suturing device 10 when viewing thesuturing device 10 along the longitudinal direction of the cylindricalmember 12 from the proximal end toward the distal end will be called theclockwise rotation (CWR) or the right-hand rotation, and thecounterclockwise rotation in the same view will be called thecounterclockwise rotation (CCW) or the left-hand rotation.

As illustrated in FIG. 4, the cylindrical member 12 is configured of acircumferential wall 32 having an inner wall surface 32 a. One portionof the circumferential wall 32 in the circumferential direction thereofis configured of a thick wall part 32 b formed thicker than the otherportions of the circumferential wall 32 having a uniform thickness. Thethick wall part 32 b is provided continuously along the longitudinaldirection of the cylindrical member 12. The inner wall surface 32 a isflat along the inside of the thick wall part 32 b. In the presentembodiment, the circumferential direction of the cylindrical member 12denotes a direction around a center axis C1 of the cylindrical member12.

A depression 34 is locally formed in one part of the cylindrical member12 along the longitudinal direction of the same. The depression 34 iscut out from the circumferential wall 32 of the cylindrical member 12(the cylindrical tube 12 a) so as to form a recess in a portion of thecylindrical member 12 corresponding to the position of the thick wallpart 32 b. The depression 34 penetrates the thick wall part 32 b of thecylindrical member 12 in the thickness direction thereof (i.e., thefront-rear direction which is the direction orthogonal to the left-rightdirection and the longitudinal direction of the cylindrical member 12,hereinafter also called depthwise direction of the depression 34) andopens to expose the inside of the cylindrical member 12 to the outsidethereof. The depression 34 is provided with a pair of sloped surfaces 34a that slope from the inner wall surface 32 a toward the outer wallsurface of the cylindrical member 12 on the distal side and proximalside of an opening 34 d formed in the depression 34. As will bedescribed later in FIG. 5, a shuttle guide member 36 is inserted in thedistal end portion of the cylindrical member 12. When the shuttle guidemember 36 is fitted into the cylindrical member 12, a first flat surface38 formed on an outer circumferential surface of the shuttle guidemember 36 closes the opening 34 d of the depression 34.

As illustrated in FIGS. 2, 3, and 4, a needle guide groove 40 is formedin the thick wall part 32 b of the cylindrical member 12 for guiding theneedle 30 in the longitudinal direction of the cylindrical member 12,i.e., in a direction parallel to the center axis C1 of the cylindricalmember 12. Through the needle guide groove 40, the needle 30 moves alonga path K parallel to the center axis C1 of the cylindrical member 12.The needle 30 is reciprocated in the longitudinal direction of thecylindrical member 12 between an advanced end position (the positionfarthest toward the distal end of the cylindrical member 12) and aretracted end position (the position farthest toward the proximal end ofthe cylindrical member 12) with a stroke longer than the openingdimension Lo of the depression 34 in the longitudinal direction of thecylindrical member 12. The opening dimension Lo is the length of astraight line leading from the intersecting point between the path K ofthe needle 30 and the proximal side of the depression 34 (i.e., aproximal edge 34 b of the opening 34 d of the depression 34) to theintersecting point between the path K of the needle 30 and the distalside of the depression 34 (i.e., a distal edge 34 c of the opening 34 dof the depression 34). Alternatively, the needle 30 may be reciprocatedin the longitudinal direction of the cylindrical member 12 at a strokelonger than the longitudinal opening dimension Lo of the opening 34 dthat penetrates the thick wall part 32 b of the cylindrical member 12 inthe thickness direction thereof to expose a part of the path K of theneedle 30 to the outside of the cylindrical member 12.

In the present embodiment, movement of the needle 30 will be called“advancing” when the needle 30 advances toward the distal side of thecylindrical member 12 and “retracting” when the needle 30 is retractedtoward the proximal side of the cylindrical member 12. The distal end ofthe needle 30 is at the advanced end A of the path K when the needle 30is in the advanced end position, and is at the retracted end B of thepath K when the needle 30 is in the retracted end position. Since theretracted end B of the path K is closer to the proximal end of thecylindrical member 12 than the proximal edge 34 b of the depression 34,the needle 30 is not exposed in the depression 34 when the needle 30 isin the retracted end position. However, the needle 30 is exposed in thedepression 34 when the needle 30 is in the advanced end position sincethe distal end of the needle 30 is at the advanced end A of the path Kwhich is closer to the distal end of the cylindrical member 12 than thedistal edge 34 c of the depression 34, and the proximal end of theneedle 30 is at a position closer to the proximal end of the cylindricalmember 12 than the proximal edge 34 b of the depression 34.

FIG. 2 illustrates the state of the needle 30 in the advanced endposition. The path K of the distal end of the needle 30 extending fromthe retracted end B to the advanced end A passes through the depression34 in the longitudinal direction of the cylindrical member 12, and theneedle groove 40 is in communication with the depression 34 through thesloped surfaces 34 a. The sloped surfaces 34 a are parts of the thickwall part 32 b. Here, the outer wall surface of the depression 34 isconfigured by the sloped surfaces 34 a and the first flat surface 38.Note that the longitudinal dimension Lh of the depression 34 in thelongitudinal direction of the cylindrical member 12 is greater than thedepthwise dimension D of the depression 34 in the depthwise direction ofthe depression 34 which is the direction orthogonal to the longitudinaldirection of the cylindrical member 12 (i.e., front-rear direction inthe present embodiment, and the left-right direction of the drawing inFIG. 3).

The shortest distance in the depthwise direction of the depression 34between the outer wall surface of the depression 34 and the path K ofthe distal end of the needle 30 changes either continuously orintermittently along the direction in which the needle 30 moves. Thatis, in a plane that includes the path K for the distal end of the needle30 and the center axis C1 of the cylindrical member 12, the distance inthe depthwise direction of the depression 34 between the needle 30 inthe advanced end position and the first flat surface 38 formed on ashuttle guide main body 52 (described later) is constant along themoving direction of the needle 30. The distance in the depthwisedirection of the depression 34 changes uniformly between the needle 30and the sloped surfaces 34 a sloped relative to the first flat surface38. The first flat surface 38 has a function for positioning biologicaltissue T received in the depression 34 as a suturing target. Theposition of the needle 30 relative to the first flat surface 38 ispreset to achieve a target piercing position for the needle 30 relativeto the thickness direction of the wall forming the biological tissue T.The needle guide groove 40 is formed in both the distal side of thedepression 34 and the proximal side of the depression 34 in order toposition the needle 30 at the target piercing position. In the presentembodiment, the distance between the first flat surface 38 and needle 30is set so that the needle 30 passes through the wall forming thebiological tissue T.

As illustrated in the enlarged view of FIG. 7, a cross section of theneedle guide groove 40 forms a circle R having a diameter equivalent tothe outer dimension of the needle 30 in order to allow passage of theneedle 30. Part of the circle R is in communication with the flat innerwall surface 32 a on the thick wall part 32 b via a slit S having awidth dimension smaller than the diameter of the needle guide groove 40.

As illustrated in FIG. 4, a fitting groove 44 is formed in thecylindrical member 12 at a position on the distal side of the depression34. A friction member 32 formed of silicone rubber or the like is fittedinto the fitting groove 44. The friction member 42 is fitted into thefitting groove 44 so as to contact the outer surface of the needle 30when the needle 30 has advanced passed the depression 34 of thecylindrical member 12 toward the advanced end position. A notched groove46 is formed in the friction member 42 at a position for receivinginsertion of the needle 30. The notched groove 46 has the samecross-sectional shape as the needle guide groove 40. This frictionmember 42 applies friction resistance to a first portion of athread-like member L (hereinafter called first thread-like member L1)that extends out from the distal end portion of the needle 30, asillustrated in FIG. 6, when the needle 30 is retracted a prescribedamount such that its distal end moves along the path K from the advancedend A toward the retracted end B of the path K, easily forming a loop LPwith a semicircular shape by causing the first thread-like member L1 toseparate from the distal end portion of the needle 30. However, thefriction member 42 is not absolutely necessary, provided that the loopLP can be formed through friction generated between the needle guidegroove 40 and the first thread-like member L1 extending from the distalend portion of the needle 30 when the needle 30 is retracted along thepath K the prescribed amount such that the distal end of the needle 30moves from the advanced end A toward the retracted end B of the path K.Alternatively, the loop LP may be formed through flexural rigidity ofthe thread-like member L itself.

In the present embodiment, a penetrating hole 48 penetrating thecircumferential wall 32 of the cylindrical member 12 is provided betweenthe depression 34 of the cylindrical member 12 and the semispherical cap14 in the longitudinal direction of the cylindrical member 12 forconfirming the operations of the shuttle 26 and the like. However, thepenetrating hole 48 does not contribute to the function of the suturingdevice 10 for forming stitches or knots and therefore is not essential.

The shuttle guide member 36 illustrated in FIG. 5 is a columnar memberthat shares the center axis C1 of the cylindrical member 12 as its owncenter axis. The shuttle guide member 36 has an outer circumferentialsurface formed with the same cross-sectional shape as the inner wallsurface 32 a, which constitutes the inner surface of the circumferentialwall 32 of the cylindrical member 12. When fitted into the cylindricalmember 12, the shuttle guide member 36 is capable of moving in thelongitudinal direction within the cylindrical member 12 but is incapableof rotating relative to the cylindrical member 12 about the center axisC1. As illustrated in FIG. 5, the shuttle guide member 36 has a secondflat surface 49 parallel to the center axis C1 on a portion of its outersurface, forming an outer circumferential surface that is D-shaped incross section and similar in shape to the inner wall surface 32 a of thecylindrical member 12. The plane passing through the second flat surface49 is parallel to the plane passing through the first flat surface 38,and the second flat surface 49 is separated farther than the first flatsurface 38 from the center axis C1.

As illustrated in detail in FIG. 5, the shuttle guide member 36 isprovided with the shuttle guide main body 52, and a shuttle guidepressing member 54. The shuttle guide main body 52 has a small-diameterfitting part 50 that protrudes toward the distal end of the cylindricalmember 12. The shuttle guide pressing member 54 is fixed to the shuttleguide main body 52 by securing pins 51 while the shuttle guide pressingmember 54 is fitted over the small-diameter fitting part 50. An annularshuttle guide groove 56 is defined between the shuttle guide main body52 and shuttle guide pressing member 54 for guiding the shuttle 26 in acircumferential direction which is a direction around the center axisC1. The shuttle guide groove 56 may be formed in the inner wall of theshuttle guide pressing member 54 following the circumferential directionalong the outer circumference of the shuttle 26.

The advanced end portion of the first operating shaft 20 passes throughthe shuttle guide main body 52, and the first operating shaft 20 iscapable of rotating relative to the shuttle guide main body 52 about thecenter axis C1. An arm 60 extends radially outward from the center axisC1 toward the inner wall surface 32 a of the circumferential wall 32 ofthe cylindrical member 12 on the advanced end portion of the firstoperating shaft 20. An arcuate pusher 58 is fixed to the arm 60 forcontacting a circumferential end of the shuttle 26 in order to move theshuttle 26 in the circumferential direction. The pusher 58 has anarcuate shape and a circumferential length that corresponds to an angleless than 180 degrees, such as approximately 160 degrees, whose vertexis the center axis C1 of the shuttle guide member 36.

The shuttle 26 has an arcuate shape and a circumferential length thatcorresponds to an angle less than 180 degrees, such as approximately 160degrees, whose vertex is the center axis C1 of the columnar shuttleguide member 36 in which is formed the shuttle guide groove 56 forguiding the shuttle 26. A holding part 62 is formed in thecircumferential center portion of the shuttle 26. The holding part 62 isconfigured of a through-hole that holds the second thread-like member L2a second portion of the thread-like member L (hereinafter called secondthread-like member L2) depicted by a dashed line in FIG. 11 by passingthe second tread-like member L2 through the holding part 62. In thepresent embodiment, the thread-like member L is a single thread in whichthe first portion (first thread-like member L1) is continuous with thesecond portion (second thread-like member L2). The thread-like member Lmay be configured of two thread-like members including a firstthread-like member L1 and a second thread-like member L2. Bothcircumferential ends of the shuttle 26 taper away from the holding part62 to form a first hook-shaped end 64 and a second hook-shaped end 66,respectively, formed with sharp angled tips.

As illustrated in FIG. 6, the proximal end of the needle 30 is coupledwith the second operating shaft 22, and the needle 30 is guided in thelongitudinal direction of the cylindrical member 12 along the centeraxis C1 by the needle guide groove 40 formed in the cylindrical member12. A distal opening 68 is formed in the distal end of the needle 30.The first thread-like member L1 inserted through the inside of thesecond operating shaft 22 and needle 30 is guided out of the needle 30through the distal opening 68.

The needle guide groove 40 formed in the cylindrical member 12 ispositioned such that the path K of the distal end of the needle 30passes through the space inside the depression 34. When an operationperformed with the second operating handle 23 in a direction toward thedistal side or the proximal side of the cylindrical member 12 in thelongitudinal direction thereof is transmitted via the second operatingshaft 22, the needle 30 is advanced or retracted along the path K.Further, when an operation performed on the second operating handle 23for rotating about the axis of the second operating shaft 22 istransmitted via the second operating shaft 22, the needle 30 is rotatedabout its axis, wrapping the first thread-like member L1 about thecircumference of the needle 30.

As illustrated by the dashed line in FIG. 3, for example, the path Kdescribed above is set inside the cylindrical member 12 to a range inthe longitudinal direction of the cylindrical member 12 between theadvanced end A positioned near the distal end of the cylindrical member12 and the retracted end B positioned a prescribed distance into theproximal side of the cylindrical member 12 from the proximal edge 34 bof the opening 34 d of the depression 34. This distance between theadvanced end A and retracted end B denotes the stroke of the distal endof the needle 30. That is, the advanced end A and retracted end Bcorrespond to stroke ends of the distal end of the needle 30.

The needle 30 is configured of a thin hollow tube having a cylindricalshape that is similar in shape to a hypodermic needle, for example. Asan alternative of the needle 30, as illustrated in FIG. 8, a needle 130having an opening 70 formed in the peripheral wall near the distal endthereof in place of the distal opening 68 may be used. With thisconfiguration, the first thread-like member L1 is exposed from theopening 70. As another alternative of the needle 30, as illustrated inFIG. 9, a needle 230 having a thread hole 72 formed near the distal endthereof in place of the distal opening 68 may be used. With thisconfiguration as well, the first portion thread-like member L1 can beanchored in the thread hole 72.

FIG. 10 illustrates the distal end face of the cylindrical member 12after the semispherical cap 14 has been removed, and a cross section ofthe shuttle guide member 36 inside the cylindrical member 12 taken alonga plane passing through the annular shuttle guide groove 56. In otherwords, the drawing illustrates the shuttle guide member 36 depicted in across section taken through a plane orthogonal to the center axis C1 andpassing through the shuttle guide groove 56 as viewed inside thecylindrical member 12 from the distal end face with the semisphericalcap 14 removed. As illustrated in FIG. 10, the shuttle guide groove 56is open in the second flat surface 49 and has an opening width Wg thatis larger than the width dimension Ws of a slit 76 illustrated in FIG.5. Note that the first thread-like member L1 and second thread-likemember L2 have been omitted from FIG. 10.

The slit 76 is formed in the portion of the shuttle guide member 36positioned on the center axis C1 side of the needle guide groove 40. Asdescribed above, the loop LP is formed in the first thread-like memberL1 extending out of the distal end of the needle 30 when the needle 30is retracted a prescribed distance along the path K in the directionfrom the advanced end A of the path K toward the retracted end B of thepath K. The slit 76 configures a loop support space for accommodatingthe shape of the loop LP and for maintaining the shape of the loop LP.The slit 76 is formed at a length in the longitudinal direction of thepath K and a depth in the radial direction of the shuttle guide member36 reaching to the first operating shaft 20. The slit 76 in the presentembodiment is formed at the same length as the path K through theshuttle guide main body 52 and the shuttle guide pressing member 54 andat a depth that reaches the outer circumferential surface of the firstoperating shaft 20.

The slit 76 extending in the longitudinal direction of the cylindricalmember 12 and the annular shuttle guide groove 56 extending in thecircumferential direction of the cylindrical member 12 intersect eachother and are in communication with each other. The diameter of theannular shuttle guide groove 56 from groove bottom to groove bottom viathe center axis C1 is set larger than the twice the distance between thesecond flat surface 49 and center axis C1 and is set to a diameter thatpasses approximately through the outer radial surface of the path K forthe needle 30 guided by the needle guide groove 40. Consequently, partof the circular path followed by the shuttle 26 that is guided by theshuttle guide groove 56 protrudes radially outward from the second flatsurface 49 formed on the shuttle guide main body 52 and shuttle guidepressing member 54.

When a rotating operation performed on the first operating handle 21 istransmitted through the first operating shaft 20, the arcuate pusher 58is rotated about the center axis C1 in a circumferential direction,contacts one circumferential end of the shuttle 26, and moves theshuttle 26 in the circumferential direction along the shuttle guidegroove 56. When the first operating handle 21 is operated toward thedistal end or proximal end of the cylindrical member 12 along thelongitudinal direction of the same, this operation is transmitted to theshuttle guide member 36 via the first operating shaft 20. Consequently,the shuttle guide member 36 is moved relative to the cylindrical member12 toward the distal side or proximal side in the longitudinal directionof the cylindrical member 12. At the same time, the shuttle 26 is pushedby the shuttle guide main body 52 or shuttle guide pressing member 54and is similarly moved relative to the needle 30 in the cylindricalmember 12 toward the distal side or proximal side of the cylindricalmember 12 along the longitudinal direction of the same.

FIGS. 11 through 15 are drawings illustrating the same view as that inFIG. 10 to describe the sequential operations for passing the shuttle 26through the loop LP formed inside the slit 76 by the first thread-likemember L1 extending from the distal end portion of the needle 30 througha rotating operation on the first operating handle 21. FIGS. 11 through15 illustrate the shuttle 26 from the distal side of the cylindricalmember 12 in the longitudinal direction.

FIG. 11 illustrates an initial state in which the loop LP is formed inthe first thread-like member L1 extending from the distal end portion ofthe needle 30 when the needle 30 is retracted the prescribed distancealong the path K in a direction from the advanced end A toward theretracted end B of the path K. The second thread-like member L2 is heldin the shuttle 26. In the initial state illustrated in FIG. 11, theshuttle 26 is in a left stop position, and the pusher 58 is in a rightstop position. In this state, when the pusher 58 is rotated about thecenter axis C1 through a right-hand rotating operation performed on thefirst operating handle 21, the pusher 58 contacts the second hook-shapedend 66 of the shuttle 26 and moves the shuttle 26 in the circumferentialdirection along the shuttle guide groove 56.

FIG. 12 illustrates a state after a right-hand rotating operation ofapproximately 70 degrees has been performed with the first operatinghandle 21, whereby the first hook-shaped end 64 of the shuttle 26 beingmoved in the X-direction has passed through the loop LP. The Y-directionindicates the moving direction of the shuttle during a left-handrotating operation on the first operating handle 21. FIG. 13 illustratesa state after a right-hand rotating operation of approximately 110degrees has been completed on the first operating handle 21, whereby thelongitudinal (circumferential) center portion of the shuttle 26 hasbecome positioned inside the loop LP. FIG. 14 illustrates a state aftera right-hand rotating operation of approximately 200 degrees has beencompleted on the first operating handle 21, whereby the entire shuttle26 has passed through the loop LP and an end of the pusher 58 has becomepositioned inside the loop LP. In a state illustrated in FIG. 14, theshuttle 26 is in a right stop position, and the pusher 58 is in aleftmost end position. Note that since the view in FIGS. 11 through 14is from the distal side of the cylindrical member 12 in the longitudinaldirection thereof, the movement of the shuttle 26 in the drawings isdepicted as left-hand rotation.

FIG. 15 illustrates a state after performing a reverse rotatingoperation (i.e., a left-hand rotation) of approximately 20 degrees onthe first operating handle from the position illustrated in FIG. 14.Through this left-hand rotation, the shuttle 26 and the pusher 58 ispivotally moved in the Y-direction until both the shuttle 26 and pusher58 are in positions rotated 180 degrees from their initial positionsillustrated in FIG. 11. In this state illustrated in FIG. 15, theshuttle 26 is in the right stop position, and the pusher 58 is in a leftstop position.

Through these operations illustrated in FIGS. 11 to 15, the secondthread-like member L2 held in the holding part 62 of the shuttle 26 ispassed through the loop LP formed in the first thread-like member L1 atthe distal end portion of the needle 30 so that the second thread-likemember L2 intersects the loop LP in the first thread-like member L1.

As illustrated in FIG. 4, the hook member 28 in the cylindrical member12 has a hook part 280 on its distal end portion that is curved into ahook shape, while the proximal end of the hook member 28 is coupled tothe third operating shaft 24. When the rotating operation performed withthe third operating handle 25 is transmitted through the third operatingshaft 24, the hook member 28 rotates about its axis (axis of the thirdoperating shaft 24) in the cylindrical member 12 and hooks or detachesfrom the first thread-like member L1 or second thread-like member L2positioned between the needle 30 and shuttle 26. Further, when anoperation on the third operating handle 25 toward the distal side of thecylindrical member 12 or proximal side of the cylindrical member 12 inthe longitudinal direction is transmitted via the third operating shaft24, the hook member 28 in the cylindrical member 12 forms slack or takesup slack in the first thread-like member L1 or second thread-like memberL2 positioned between the needle 30 and shuttle 26.

In other words, the hook member 28 capable of hooking a thread-likemember L positioned between the needle 30 and shuttle 26 in thecylindrical member 12 is provided so as to be movable in thelongitudinal direction of the cylindrical member 12. Note that the hookmember 28 may also possess a latch for opening and closing the openingin the hook part 280. Alternatively, the hook part 280 may be configuredof a shape memory alloy, and the opening in the hook part 280 may beselectively opened and closed by raising or lowering the temperature. Inthis case, the hook member 28 can be more easily unhooked from athread-like member by increasing the opening in the hook part 280.

A suturing target clamping mechanism 78 for placing the biologicaltissue T in contact with the depression 34 to immobilize the biologicaltissue T is provided in the cylindrical member 12. The biological tissueT constitutes the suturing target and may be the left atrial appendagethat protrudes locally as a pouch from the wall of the left ventricle ofthe heart, for example. The suturing target clamping mechanism 78 isconfigured of a balloon (expanding bag) 78 a disposed on the outer wallsurface of the circumferential wall 32 of the cylindrical member 12.

For example, the suturing target clamping mechanism 78 may be disposedin an area of the cylindrical member 12 positioned on the opposite sideof the center axis C1 from the depression 34, as illustrated in FIG. 3.In other words, in the suturing device 10 of the present embodiment, thedepression 34 is formed in the front surface of the outer wall 32 of thecylindrical member 12, while the suturing target clamping mechanism 78is disposed on the rear surface thereof.

The suturing target clamping mechanism 78 may be configured of aplurality of balloons or a plurality of other members. In other words,instead of a balloon formed of a resin material, the suturing targetclamping mechanism 78 may be configured of a metallic member, providedthat the suturing target clamping mechanism 78 can immobilize thebiological tissue T. A hose (not illustrated) for supplying pressurizedfluid to the suturing target clamping mechanism 78 is connected to theballoon 78 a configuring the suturing target clamping mechanism 78.

Here, the positions of the shuttle 26 and needle 30 will be describedusing the expressions advanced end and retracted end, while the positionof the hook member 28 will be described using the expressions advancedend, advanced, retracted, and retracted end.

Hereinafter, the shuttle 26 being in the retracted end positionsignifies that the shuttle 26 is positioned farther toward the retractedside in the longitudinal direction of the cylindrical member 12 than theproximal end of the cylindrical member 12. The shuttle 26 being in theadvanced end position signifies that the shuttle 26 is positionedfarther toward the distal side (advanced side) in the longitudinaldirection of the cylindrical member 12 than the distal edge 34 c of thedepression 34 in the cylindrical member 12.

The needle 30 being in the advanced end position signifies that thedistal end of the needle 30 is farther toward the distal side (advancedside) in the longitudinal direction of the cylindrical member 12 thanthe distal edge 34 c of the opening 34 d of the depression 34 in thecylindrical member 12 and farther toward the distal side (advanced side)of the cylindrical member 12 than the shuttle 26 positioned in theadvanced end position. In the present embodiment, as described above,the needle 30 being in the advanced end position denotes that the distalend of the needle 30 is at the advanced end A of the path K illustratedin FIG. 3. The needle 30 being in the retracted end position denotesthat the distal end of the needle 30 is positioned farther toward theproximal side (retracted side) in the longitudinal direction of thecylindrical member 12 than the proximal edge 34 b of the opening 34 d ofthe depression 34 in the cylindrical member 12. In the presentembodiment, as described above, the needle 30 being in the retracted endposition specifies that the distal end of the needle 30 is at theretracted end B of the path K illustrated in FIG. 3.

The hook member 28 being in the advanced position denotes that the top280 a of the hook part 280 constituting the hook member 28 is positionedat the proximal edge 34 b of the depression 34 in the cylindrical member12. The hook member 28 being at the advanced end position denotes thatthe tip 280 b of the hook part 280 constituting the hook member 28 ispositioned farther toward the distal side (advanced side) of thecylindrical member 12 than when the hook member 28 is in the advancedposition. The hook member 28 being in the retracted position denotesthat the tip 280 b of the hook part 280 constituting the hook member 28is positioned at the proximal end of the cylindrical member 12. The hookmember 28 being in the retracted end position denotes that the top 280 aof the hook part 280 constituting the hook member 28 is positionedfarther toward the retracted side than the proximal end of thecylindrical member 12.

Next, a stitch forming operation and an ensuing knot forming operationfor closing from the inside an opening in the biological tissue T, suchas an opening in the pouch-like left atrial appendage at the site of anintra-atrial thrombus formation, will be described for the suturingdevice 10 having the structure described above.

<Stitch Forming Operation>

FIGS. 16 through 24 are longitudinal cross-sectional views of thesuturing device 10 for describing the sequence of operations for forminga single stitch in the biological tissue T. FIGS. 25 through 32 areschematic diagrams illustrating the sequence of operations for forming asingle stitch using the shuttle 26, hook member 28, and needle 30. FIG.33 is a timing diagram describing the operations of each member thatcontributes to the formation of a single stitch in the biological tissueT.

First, by operating the tubular coupling member 16 (see FIG. 1), thedistal end portion of the suturing device 10 is inserted into thepouch-like biological tissue T, as indicated at timing (a) in FIG. 33.FIG. 16 is a longitudinal cross-sectional view of the suturing device 10illustrating the initial state similar to the state illustrated in FIG.11. FIG. 25 illustrates the insertion step for inserting the distal endof the suturing device 10 into the pouch-like biological tissue T (notillustrated). In this state, the needle 30 is in the retracted endposition, and the first thread-like member L1 and second thread-likemember L2 formed continuously with the first thread-like member L1 thatextend between the distal end of the needle 30 and the holding part 62of the shuttle 26 are hooked around the hook part 280 of the hook member28 in the retracted position on the proximal side of the cylindricalmember 12. At this time, the hook member 28 is in the retractedposition.

Next, a pressurized fluid is supplied through the hose (not illustrated)into the balloon 78 a configuring the suturing target clamping mechanism78 provided on the rear surface of the suturing device 10 that isinserted inside the pouch-like biological tissue T, as indicated attiming (b) in FIG. 33. As the balloon 78 a expands from the pressurizedfluid, tension is generated in the biological tissue T, causing aportion of the biological tissue T to be received and immobilized in thedepression 34 of the suturing device 10. When a portion of thebiological tissue T is immobilized in the depression 34 in this way, thepath K becomes aligned with a position inside the thickness of the wallconstituting the biological tissue T. FIG. 17 is a longitudinalcross-sectional view illustrating the distal end portion of the suturingdevice 10 in this state, and FIG. 25 also illustrates this biologicaltissue fixing step for fixing the biological tissue T (not illustrated)with respect to the distal end portion of the suturing device 10.

Next, through an operation to advance the second operating handle 23,the needle 30 advances toward the advanced end position while the firstthread-like member L1 equivalent to the advancing distance of the needle30 is supplied into the needle 30, as indicated at timing (c) in FIG.33. The needle 30 and the first thread-like member L1 (needle thread(upper thread)) pass through the wall of the biological tissue Tpositioned in the depression 34. FIG. 18 is a longitudinalcross-sectional view illustrating the distal end portion of the suturingdevice 10 in this state. FIG. 26 illustrates this needle piercing stepfor piercing the needle 30 into the wall of the biological tissue T (notillustrated) positioned in the depression 34.

Through an operation to retract the second operating handle 23, theneedle 30 is retracted by a small prescribed amount toward the proximalside of the cylindrical member 12, as indicated at timing (d) in FIG.33. Through frictional resistance between the friction member 42 and thefirst thread-like member L1 positioned outside the distal end portion ofthe needle 30, a loop LP is formed at the distal end portion of theneedle 30. This loop LP is formed in the loop support space within theslit 76 provided in the shuttle guide member 36 along a radial directionof the center axis C1, as illustrated in FIG. 11. FIG. 19 is alongitudinal cross-sectional view illustrating the distal end portion ofthe suturing device 10 in this state. FIG. 27 illustrates this loopforming step for forming a loop LP in the first thread-like member L1.

Next, a right-hand rotating operation is performed with the firstoperating handle 21 to move the pusher 58 around the center axis C1, asindicated at timing (e) in FIG. 33. At this time, the pusher 58 contactsthe second hook-shaped end 66 of the shuttle 26, moving the shuttle 26in the circumferential direction along the shuttle guide groove 56 sothat the shuttle 26 passes through the loop LP, as illustrated in FIGS.12 through 14. FIG. 20 is a longitudinal cross-sectional viewillustrating a state after the first operating handle 21 has undergone aright-hand rotating operation of approximately 110 degrees andillustrating the distal end portion of the suturing device 10 when thelongitudinal (circumferential) center portion of the shuttle 26 ispositioned inside the loop LP. FIG. 28 illustrates a loop threading stepwith the shuttle 26. Through this step, the second thread-like member L2held in the shuttle 26 is passed through the loop LP formed in the firstthread-like member L1 at the distal end portion of the needle 30 so thatthe second thread-like member L2 intersects the loop LP of the firstthread-like member L1.

Next, a retracting operation is performed on the second operating handle23 to move the needle 30 so that the distal end of the needle 30 isretracted to a position at the retracted end B of the path K, asindicated at timing (f) in FIG. 33. Further, a left-hand rotatingoperation is performed with the first operating handle 21 to move thepusher 58 from the leftmost end position to the left stop position, asillustrated in FIGS. 14 and 15. Through these operations, the needle 30is extracted from the biological tissue T, and the first thread-likemember L1 (needle thread (upper thread)) is pulled and tightened,reducing the size of the loop LP. At this time, the first thread-likemember L1 begins passing through the needle 30 and is supplied into theneedle 30 in response to the retraction of the same so that the secondthread-like member L2 is not drawn into the biological tissue T. Thisoperation produces a stitch N with thread tension, such as thoseillustrated in FIGS. 34 and 35. FIG. 21 is a longitudinalcross-sectional view illustrating the distal end portion of the suturingdevice 10 in this state. FIG. 29 illustrates this loop tightening stepfor tightening the loop LP and producing a stitch N.

A retracting operation is also performed on the first operating handle21 to retract the shuttle guide member 36 to the proximal side of thecylindrical member 12 so that the shuttle 26 retained in the shuttleguide member 36 is retracted toward the retracted end position, asindicated at timing (g) in FIG. 33. This retracting movement of theshuttle 26 may be performed at the same time the needle 30 is retractedto the retracted end position at timing (f). In association with theretracting movement of the shuttle 26, the third operating handle 25 isoperated to advance the hook member 28 until the hook part 280 reaches aposition near the distal end of the needle 30 in the advanced endposition. FIG. 22 is a longitudinal cross-sectional view illustratingthe distal end portion of the suturing device 10 in this state. FIG. 30illustrates this hook advancing step for advancing the hook member 28.When the shuttle 26 is retracted to the retracted position, the hookmember 28 is advanced toward the distal end of the cylindrical member12. At this time, the first operating shaft 20 moves in the directionfrom the proximal end toward the distal end of the cylindrical member 12a distance corresponding to half the distance that the shuttle 26 isretracted to the retracted end position.

Next, an advancing operation and a half-turn operation are performed onthe third operating handle 25, as indicated at timing (h) in FIG. 33,whereby the hook member 28 is moved farther toward the distal side ofthe cylindrical member 12 until the hook part 280 is separated from theloop LP, and is subsequently rotated a half turn to detach the hook part280 from the loop LP. Further, a retracting operation is performed onthe third operating handle 25, at timing (h) in FIG. 33 (not indicated),to move the hook member 28 from the advanced end position to a positionfarther toward the retracted side than the retracted end position. FIG.23 is a longitudinal cross-sectional view illustrating the distal endportion of the suturing device 10 in this state. FIG. 31 illustratesthis hook-thread detaching step for detaching the hook part 280 from theloop LP. FIGS. 23 and 31 illustrate the state after the hook member 28has been turned in a right-hand rotation at its advanced end position tobe detached from the loop LP and subsequently retracted farther towardthe retracted side than the proximal end of the cylindrical member 12.Consequently, the hook member 28 is not illustrated in FIGS. 23 and 32.Subsequently, an advancing operation is performed on the third operatinghandle 25 to move the hook member 28 back to the advanced end position.At this time, the hook member 28 is detached from the loop LP at itsadvanced end position. This movement of the hook member 28 is also notindicated but is performed at the timing (h) in FIG. 33.

Next, a retracting operation is performed on the third operating handle25, as indicated at timing (i) in FIG. 33, whereby the hook member 28 isretracted to the retracted end position near the position of the shuttle26 in the retracted end position. When the hook member 28 is in theretracted end position, the hook part 280 is detached from the firstthread-like member L1. Subsequently, a left-hand rotating operation isperformed with the third operating handle 25. At this time, the hookmember 28 is also moved slightly toward the distal side of thecylindrical member 12 so that the hook part 280 is positioned on thedistal side of the cylindrical member 12 (on the advanced side) relativeto the shuttle 26 while the hook member 28 is rotated one turn. The hookpart 280 of the hook member 28 hooks the second thread-like member L2positioned between the reduced loop LP and the shuttle 26. FIG. 24 is alongitudinal cross-sectional view illustrating the distal end portion ofthe suturing device 10 in this state. FIG. 32 illustrates this threadhooking step for hooking the second thread-like member L2 by the hookpart 280 of the hook member 28.

Subsequently, the balloon 78 a configuring the suturing target clampingmechanism 78 provided on the rear surface of the suturing device 10 isshrunk, as indicated at timing (j) in FIG. 33, by discharging thepressurized fluid from the balloon 78 a through the hose (notillustrated). At the same time, an advancing operation is performed withthe first operating handle 21 to advance the shuttle guide member 36accommodating the shuttle 26 to the position illustrated in FIG. 20,i.e., the advanced end position, and an advancing operation and rotatingoperation are performed with the third operating handle 25 to advancethe hook member 28 to the position illustrated in FIG. 17 and to returnthe hook member 28 half turn. These operations restore the components totheir positions in the initial state illustrated in FIG. 17 for thestart of a stitch. Thereafter, a plurality of stitches N are formed insequence by repeatedly rotating the suturing device 10 within thepouch-like biological tissue T to the next stitch forming position andperforming the same stitch forming operations described above. FIG. 34is a schematic diagram illustrating this operation.

After stitches N have been formed across substantially the entire innercircumferential surface of the biological tissue T, as described above,a knot M is formed with the suturing device 10 using the firstthread-like member L1 and second thread-like member L2, as illustratedin the sample schematic diagram of FIG. 35, so that the stitches Ncannot unravel. FIG. 36 is a cross-sectional view of the structuresillustrated in FIG. 35. FIG. 37 is a developed view illustrating aplurality of stitches N formed annularly in succession along the innercircumferential surface of the biological tissue T protruding in apouch-like formation, and a knot M formed following the stitches N withthe first thread-like member L1 and second thread-like member L2. Asillustrated in FIG. 37, the first thread-like member L1 and secondthread-like member L2 are different portions of the same thread-likemember L. The first thread-like member L1 constitutes the section of thethread-like member L held by the needle 30 and drawn out from the distalend portion of the needle 30 to the biological tissue T, and the secondthread-like member L2 constitutes the section of the thread-like memberL held in the shuttle 26 and drawn out from the shuttle 26 to thebiological tissue T.

<Knot Forming Operation>

FIGS. 38 through 43 are schematic diagrams illustrating a sequence ofoperations performed with the suturing device 10 to form a half hitchusing the first thread-like member L1 and second thread-like member L2.FIG. 44 is a schematic diagram illustrating the primitive form of a knotM1 obtained by performing this half hitch forming operation twice. FIG.45 illustrates the granny knot M1 produced by reshaping the primitiveform in FIG. 44.

FIGS. 46 and 47 are timing diagrams illustrating the operations ofmembers that contribute to formation of a single half hitch. The timingdiagram in FIG. 46 illustrates an operation pattern A in which theneedle 30 has a right-hand rotation for winding the first thread-likemember L1 (denoted NEEDLE CWR in FIG. 50 described later) and theshuttle 26 passes through the loop LP while moving in a right-handcircumferential direction (denoted SHUTTLE CWR in FIG. 50 describedlater). The timing diagram in FIG. 47 illustrates an operation pattern Bin which the needle 30 has a left-hand rotation for winding the firstportion L1 of the thread-like member L (denoted NEEDLE CCR in FIG. 50described later) and the shuttle 26 passes through the loop LP whilemoving in a left-hand circumferential direction (denoted SHUTTLE CCR inFIG. 50 described later). The balloon 78 a configuring the suturingtarget clamping mechanism 78 is not used in the knot forming operationssince the needle 30 is not inserted into the biological tissue T.Further, the hook member 28 has been omitted from FIGS. 38 through 44.

First, while the distal end portion of the suturing device 10 remainsinserted in the pouch-like biological tissue T, the balloon 78 aconstituting the suturing target clamping mechanism 78 disposed on therear surface of the suturing device 10 is reduced in size to remove thebiological tissue T from the depression 34, as indicated at timing (k)in FIG. 46. FIG. 38 illustrates this initial step for forming a knot. Inthe initial state of this knot forming operation, the needle 30 is inthe retracted end position and the hook member 28 is in the proximalside of the cylindrical member 12, specifically, in the retractedposition.

Next, an advancing operation performed with the second operating handle23 advances the needle 30 a prescribed distance into the depression 34,while a rotating operation performed with the second operating handle 23rotates the needle 30 one right-hand turn during the needle 30 beingpositioned in the depression 34, as indicated at timing (l) in FIG. 46.The rotation of the needle 30 causes the first portion L1 of thethread-like member L to wrap around the needle 30. Note that the needle30 need not be rotated exactly one turn, but should be rotatedapproximately between 0.5 and 1.5 turns, for example. FIG. 39illustrates this thread winding step for winding the thread around theneedle 30.

Next, an advancing operation performed on the second operating handle 23advances the needle 30 farther toward the distal side of the cylindricalmember 12 to the advanced end position corresponding to the advanced endA of the path K, as indicated a timing (m) in FIG. 46. FIG. 40illustrates this needle advancing step for advancing the needle 30 tothe advanced end position.

Further, a retracting operation is performed with the second operatinghandle 23 to retract the needle 30 a small prescribed distance towardthe proximal side of the cylindrical member 12, as indicated at timing(n) in FIG. 46. Through this operation, the first thread-like member L1positioned outside the distal end portion of the needle 30 forms a loopLP on the distal end portion of the needle 30 owing to the frictionalresistance from the friction member 42. This loop LP is formed betweenone end (hereinafter called first end) and another end (hereinaftercalled second end) of the first thread-like member L1 so that a firstintersecting point P1 and a second intersecting point P2 of the firstthread-like member L1 intersect each other. Here, the first intersectingpoint P1 and second intersecting point P2 are positioned in order fromthe second end toward the first end. The loop LP is formed in the loopsupport space in the slit 76 provided in the shuttle guide member 36 inthe radial direction toward the center axis C1 thereof. FIG. 41illustrates this loop forming step for forming the loop LP in the firstthread-like member L1.

Next, a right-hand rotating operation performed on the first operatinghandle 21 pivotally moves the pusher 58 about the center axis C1, asindicated at timing (o) of FIG. 46. At this time, the pusher 58 contactsthe second hook-shaped end 66 of the shuttle 26, moving the shuttle 26in a circumferential direction along the shuttle guide groove 56 so thatthe shuttle 26 passes through the loop LP. FIG. 42 illustrates this loopthreading step. In this step, the end of the second thread-like memberL2 held in the shuttle 26 is passed through the loop LP formed at thedistal end portion of the needle 30 by the first thread-like member L1intersecting itself at the first intersecting point P1 and secondintersecting point P2 in the direction from the second intersectingpoint P2 toward the first intersecting point P1 of the loop LP.Accordingly, the second thread-like member L2 passes relative to theloop LP of the first thread-like member L1.

Next, a retracting operation is performed on the second operating handle23 to retract the needle 30 until the distal end of the needle 30 ispositioned at the retracted end B of the path K, as indicated at timing(p) in FIG. 46. Through this action, a half hitch is formed with thesecond thread-like member L2 passing through the loop LP formed in thefirst thread-like member L1 (needle thread (upper thread)). FIG. 43illustrates this needle retracting step for forming a half hitch.

The operations specified at timings (q), (r), (s), and (t) in FIG. 46are performed to return the shuttle 26 and hook member 28 to theirinitial positions and are identical to the operations at timings (g),(h), (i), and (j) in FIG. 33 except that the balloon 78 a configuringthe suturing target clamping mechanism 78 remains reduced in size. Notethat the operations at timings (q), (r), (s), and (t) in FIG. 47described later are also identical to those at timings (g), (h), (i),and (j) in FIG. 33 except that the balloon 78 a configuring the suturingtarget clamping mechanism 78 remains reduced in size.

Thereafter, the operations for forming a half hitch illustrated in FIGS.38 through 43 are repeated to form the primitive form of a granny knotM1, as illustrated in FIG. 44. FIG. 45 illustrates the granny knot M1that is reshaped from the primitive form described above by tighteningthe first thread-like member L1 and second thread-like member L2. Inother words, the granny knot M1 is formed by forming half hitches in twostages using the same operation pattern. After the granny knot M1 hasbeen formed in this way, the suturing device 10 is extracted from thebiological tissue T to tighten the first thread-like member L1 andsecond thread-like member L2 and, when necessary, the same operationsdescribed above may be repeated to form an additional granny knot M1 orthe like. Subsequently, the process is completed by cutting off the endsof the first thread-like member L1 and second thread-like member L2.

FIG. 47 differs from FIG. 46 in that the needle 30 is rotated oneleft-hand turn while positioned in the depression 34 through a rotatingoperation on the second operating handle 23 at timing (l) to wind thefirst thread-like member L1 about the needle 30, and in that the shuttle26 is passed through the loop LP in the left-hand circumferentialdirection through a left-hand rotating operation on the first operatinghandle 21 when passing through the shuttle 26 through the loop LP attiming (o). All other operations in FIG. 47 are identical to those inFIG. 46. By performing the half hitch forming operations twice accordingto an operation pattern B illustrated in FIG. 47, the granny knot M1illustrated in FIG. 45 can be obtained.

However, the knot M may be formed by first executing the half hitchforming operations according to an operation pattern A illustrated inFIG. 46 and subsequently executing the half hitch forming operationsaccording to the operation pattern B illustrated in FIG. 47. In thiscase, the primitive form of a square knot M2 will be formed, asillustrated in FIG. 48. FIG. 49 illustrates the square knot M2 that isreshaped from the primitive form described above by tightening the firstthread-like member L1 and second thread-like member L2. This square knotM2 may also be formed by first executing the half hitch formingoperations according to the operation pattern B illustrated in FIG. 47and subsequently executing the half hitch operations according to theoperation pattern A illustrated in FIG. 46. Hence, the square knot M2 isformed by forming half hitches in two stages according to differentoperation patterns. FIG. 50 is a table illustrating the relationshipsbetween first-stage operation patterns and second-stage operationpatterns and the types of knots they produce.

FIG. 51 illustrates the state in which the second thread-like member L2held in the holding part 62 of the shuttle 26 has been passed throughthe loop LP formed in the first thread-like member L1 at the distal endportion of the needle 30 through the operations from FIGS. 38 through42. This loop LP may maintain an equivalent topology with a closed path.Here, the second thread-like member L2 constituting one end portion ofthe thread-like member L formed continuously with the first thread-likemember L1 constituting another end portion of the thread-like member Lmust be passed through the loop LP formed in the first thread-likemember L1 in order to form a half hitch as a fundamental operation forforming a secure knot M. However, among the two directions in which thesecond thread-like member L2 can be passed through the loop LP, onedirection forms a knot and the other does not. A knot is not formed whenthe second thread-like member L2 is passed in the other directionbecause the loop LP disappears before the second thread-like member L2can pass therethrough and is no longer a loop at the moment of passing.This concept will be described in greater detail with reference to FIG.52.

In FIG. 52 a loop LP defined by a virtual axis E and the firstthread-like member L1 in which the loop LP is formed are projected ontoa projecting plane P orthogonal to the virtual axis E. When theprojected image of the first thread-like member L (black lines) forms aclosed path, the parts of the actual first thread-like member L1 (whitelines) projected on the intersecting point of this closed path is amultilevel intersection configured of two points on the firstthread-like member L, and specifically a first intersecting point P1that is closer to a first position, which is a first end of thethread-like member L (the fixed end, and specifically the end on thebiological tissue T side in the present embodiment), and a secondintersecting point P2 that is farther from the first position (aposition inside the needle 30). The portion of the first thread-likemember L1 depicted with a dashed white line in FIG. 52 indicates theportion positioned below the projecting plane P. In this state, a knotcan be formed by passing the second thread-like member L2 held in theholding part 62 of the shuttle 26 through the loop LP in a directionfrom the side of the second intersecting point P2 farther from the firstposition toward the side of the first intersecting point P1 closer tothe first position, i.e., in the direction of the arrow indicating thevirtual axis E.

This relationship is always satisfied regardless how the virtual axis Eis established. In other words, when the loop LP is formed by theintersection of the first intersecting point P1 nearer to the firstposition on the side of the biological tissue T, which is the suturingtarget of the first thread-like member L1, and the second intersectingpoint P2 farther than the first intersecting point P1 from the firstposition through the operations in FIGS. 38 through 42, a half hitch isformed by passing the holding part 62 of the shuttle 26 holding thesecond thread-like member L2 through the loop LP in a direction from theside of the second intersecting point P2 toward the side of the firstintersecting point P1.

Using the example of FIG. 52, if the second intersecting point P2 is afirst point on the first thread-like member L1 and the firstintersecting point P1 is a second point on the first thread-like memberL1 that is farther than the first point from the needle 30, a knot isformed by passing the holding part 62 holding the second thread-likemember L2 through the loop LP formed by the intersection of the firstpoint on the first thread-like member L1 and the second point on thefirst thread-like member L1 farther than the first point from the needle30 in the direction from the first point toward the second point. Thefirst operating shaft 20 of the embodiment is operated in this manner.

The suturing device 10 according to the present embodiment describedabove includes: a cylindrical member 12; a needle 30; a depression 30;and a shuttle 26. The cylindrical member 12 has an elongated shapeextending in a longitudinal direction and functions as a casing. Theneedle 30 is positioned in the cylindrical member 12 and has anelongated shape extending in the longitudinal direction of thecylindrical member 12. The needle 30 is configured to hold a firstthread-like member L1 and to reciprocally move forward and backward inthe longitudinal direction of the cylindrical member 12 to form a loopLP in the first thread-like member L1. The needle 30 has a distal endreciprocally moving along a path K extending between an advanced end Aand a retracted end B in the longitudinal direction in the reciprocalmovement of the needle 30 in the longitudinal direction. The advancedend A is positioned on the distal side of the cylindrical member 12 thanthe retracted end B in the longitudinal direction thereof. Thedepression 34 is formed in a circumferential wall 32 of the cylindricalmember 12 and is positioned between the advanced end A and the retractedend B in the longitudinal direction. The depression 34 is configured toexpose the needle 30 to an outside of the cylindrical member 12. Theshuttle 26 includes a holding part 62. The holding part 62 is configuredto hold a second thread-like member L2. The shuttle 26 is configured tomove within the cylindrical member 12 at a position between the advancedend A and the retracted end B in the longitudinal direction to changerelative position between the second thread-like member L2 and the loopLP. Accordingly, through operations for moving the shuttle 26 in thecylindrical member 12, the second thread-like member L2 held in theholding part 62 is moved relative to the loop LP, enabling a stitch N ora knot M to be formed easily and reliably through mechanical operationsbased on simple manipulations.

In the suturing device 10 according to the present embodiment, thedepression 34 has a longitudinal dimension Lh in the longitudinaldirection and a depth dimension D in the depthwise direction, and thedepth dimension D is smaller than the longitudinal dimension Lh.Accordingly, the biological tissue T as the suturing target can be fixedin a position along the depthwise direction of the depression 34 whenreceived in the depression 34. Since the needle 30 passes through thebiological tissue T while the biological tissue T is in this state, astitch can be obtained by passing the first thread-like member L1through the wall of the biological tissue T at a fixed position in thethickness direction thereof.

According to the suturing device 10 of the present embodiment, theneedle 30 provides a stroke length in the longitudinal direction. Thedepression 34 has a longitudinal dimension Lh in the longitudinaldirection of the cylindrical member 12, and the stroke length is greaterthan the longitudinal dimension Lh of the depression 34. Accordingly, bypassing the shuttle 26 that holds the second thread-like member L2 inthe holding part 62 through the loop LP in the first thread-like memberL1 formed at the distal end of the needle 30 at a prescribed position inthe cylindrical member 12 corresponding to the advanced end A of thepath K, the first thread-like member L1 forming the loop LP can be madeto intersect the second thread-like member L2 to form a half hitch.

In the suturing device 10 according to the present embodiment, thecylindrical member 12 is used as a long hollow casing, thereby easilyinexpensively obtaining a small-diameter casing that is easy to handle.

According to the suturing device 10 of the present embodiment, theneedle 30 is configured to permit the first thread-like member L1extending from the distal end of the needle 30 to be shaped into theloop LP when the distal end is retracted along the path K in thelongitudinal direction. Accordingly, the loop LP can easily be formedaccording to a simple construction by retracting the needle 30.

In the suturing device 10 according to the present embodiment, theshuttle 26 is provided on one end with a first hook-shaped end 64. Thefirst hook-shaped end 64 is configured to acquire the loop LP. The firsthook-shaped end 64 is configured to permit the second thread-like memberL2 held in the holding part 62 to pass through the loop LP. In this way,the shuttle 26 having the holding part 62 that holds the secondthread-like member L2 can be easily passed through the loop LP formed atthe distal end portion of the needle 30.

According to the suturing device 10 of the present embodiment, theshuttle 26 is provided on another end with a second hook-shaped end 66.The second hook-shaped end 66 is configured to acquire the loop LPformed at the distal end portion of the needle 30. The secondhook-shaped end 66 is configured to permit the second thread-like memberL2 held in the holding part 62 to pass through the loop LP. The firsthook-shaped end 64 and the second hook-shaped end 66 are positionedopposite to each other with respect to the holding part 62. In this way,the shuttle 26 can easily pass through the loop LP formed at the distalend portion of the needle 30 in both right-hand and left-hand rotatingdirections.

In the suturing device 10 according to the present embodiment, the firsthook-shaped end 64 of the shuttle 26 has an end with an acutely angledtip. The first hook-shaped end 64 tapers away from the holding part 62toward the end. The second hook-shaped end 66 of the shuttle 26 has anend with an acutely angled tip. The second hook-shaped end 66 tapers wayfrom the holding part 62 toward the end. This shape allows the shuttle26 to easily acquire the loop LP formed on the distal end portion of theneedle 30, even when the shape of the loop LP varies.

The suturing device 10 according to the present embodiment furtherincludes: a shuttle guide member 36; and a first operating shaft 20. Theshuttle guide member 36 is fitted within the cylindrical member 12 andhas a cylindrical shape extending in the longitudinal direction of thecylindrical member 12 and providing a circumferential direction. Thecylindrical member 12 has a center axis C1 extending in the longitudinaldirection. The shuttle guide member 36 is movable relative to thecylindrical member along the center axis C1 and non-rotatable relativeto the cylindrical member 12 about the center axis C1. The shuttle guidemember 36 includes a shuttle guide groove 56. The shuttle guide grooveis formed into an annular shape. The shuttle guide groove 56 isconfigured to guide the shuttle 26 in the circumferential direction ofthe shuttle guide member 36. The first operating shaft 20 has an endportion connected to the shuttle guide member 36 such that the endportion is immovable relative to the shuttle guide member 36 along thecenter axis C1 and rotatable relative to the shuttle guide member 36about the center axis C1. The rotation of the first operating shaft 20in a right-hand (first) rotating direction about the center axis C1permits the shuttle 26 to pass through the loop LP such that the firsthook-shaped end 64 is a leading end in the movement of the shuttle 26within the cylindrical member 12 at the prescribed position. Therotation of the first operating shaft 20 in a left-hand (second)rotating direction opposite to the right-hand rotating direction aboutthe center axis C1 permits the shuttle 26 to pass through the loop LPsuch that the second hook-shaped end 66 is a leading end in the movementof the shuttle 26 within the cylindrical member 12 at the prescribedposition. In this way, the shuttle 26 can be moved in circumferentialdirections so as to be threaded through the loop LP by rotating thefirst operating shaft 20 about the center axis C1. Further, by operatingthe first operating shaft 20 in a direction along the center axis C1,the shuttle 26 can be moved toward the proximal side to tighten thesecond thread-like member L2 held in the holding part 62 of the shuttle26. Further, since the holding part 62 of the shuttle 26 can be passedthrough the loop LP formed at the distal end portion of the needle 30 inboth a first rotating direction and a second rotating direction aboutthe center axis C1 of the shuttle guide member 36, the shuttle 26 neednot be reciprocated after forming each stitch N, thereby simplifyingsuturing operations.

The suturing device 10 according to the present embodiment furtherincludes: a shuttle guide member 36; and a first operating shaft 20. Theshuttle guide member 36 is fitted within the cylindrical member 12 andhas a cylindrical shape extending in the longitudinal direction of thecylindrical member 12 and providing a circumferential direction. Thecylindrical member 12 has a center axis C1 extending in the longitudinaldirection. The shuttle guide member 36 is movable relative to thecylindrical member 12 along the center axis C1 and non-rotatablerelative to the cylindrical member 12 about the center axis C1. Theshuttle guide member 36 includes a guide portion 56. The guide portion56 is formed into an annular shape. The guide portion 56 is configuredto guide the shuttle 26 in the circumferential direction. The firstoperating shaft 20 has an end portion connected to the shuttle guidemember 36 such that the end portion of the first operating shaft 20 isimmovable relative to the shuttle guide member 36 along the center axisC1 and rotatable relative to the shuttle guide member 36 about thecenter axis C1. In this way, the shuttle 26 can be moved incircumferential directions so as to be threaded through the loop LP byrotating the first operating shaft 20 about the center axis C1. Further,by operating the first operating shaft 20 in a direction along thecenter axis C1, the shuttle 26 can be moved toward the proximal side ofthe cylindrical member 12 to tighten the second thread-like member L2held in the holding part 62 of the shuttle 26.

The suturing device 10 according to the present embodiment furtherincludes a pusher 58. The pusher 58 is fixed to the end portion of thefirst operating shaft 20. The pusher 58 is configured to abut againstone of the one end portion and the other end portion of the shuttle 26to move the shuttle along the shuttle guide groove 56. Thisconfiguration allows the shuttle 26 to be easily moved in thecircumferential directions by rotating the first operating shaft 20about the center axis C1.

In the suturing device 10 according to the present embodiment, thepusher 58 has an arcuate shape with a circumferential lengthcorresponding to an angle less than 180 degrees whose vertex is thecenter axis C1. Hence, by using the pusher 58 to move the shuttle 26having an arcuate shape with a circumferential length that correspondsto an angle less than 180 degrees whose vertex is the center axis, theshuttle 26 can be passed through the loop LP formed at the distal endportion of the needle 30 each time the shuttle 26 is reciprocally movedin the circumferential directions around the center axis C1 of theshuttle guide member 36.

In the suturing device 10 of the present embodiment, the shuttle 26 andthe pusher 58 are spaced away from each other in the circumferentialdirection. This configuration can absorb any variation in the mount thatthe first operating shaft 20 is operated in the right-hand (first)rotating direction to move the shuttle 26.

In the suturing device 10 of the present embodiment, the shuttle has anarcuate shape with a circumferential length corresponding to an angleless than 180 degrees whose vertex is the center axis C1 of the shuttleguide member 36. In this way, the shuttle 26 can be passed through theloop LP formed at the distal end portion of the needle 30 each time theshuttle 26 is reciprocally moved in the circumferential directionsaround the center axis C1 of the shuttle guide member 36.

In the suturing device 10 according to the present embodiment, theshuttle guide member 36 has a loop support space. The loop support spaceextends in the longitudinal direction of the cylindrical member and incommunication with the shuttle guide groove 56. The loop support spaceis configured to accommodate therein the first thread-like member L1positioned on the path K for the distal end of the needle 30. With thisconfiguration, the first thread-like member L1 positioned on the path Kfor the distal end of the needle 30 can be prevented from interferingwith other members, and the loop LP in the first thread-like member L1formed at the distal end portion of the needle 30 can be positionedinside the shuttle guide groove 56.

According to the suturing device 10 of the present embodiment, theshuttle guide member includes: a shuttle guide main body 52; and ashuttle guide pressing member 54. The shuttle guide main body 52 has acylindrical shape extending in the longitudinal direction of thecylindrical member 12. The shuttle guide main body 52 is reciprocallymovable relative to the cylindrical member 12 in the longitudinaldirection thereof. The end portion of the first operating shaft 20penetrates through the shuttle guide main body 52. The shuttle guidepressing member 54 is fixed to the shuttle guide main body 52 and has ashortened cylindrical shape extending in the longitudinal direction ofthe cylindrical member 12. The shuttle guide pressing member 54 formsthe shuttle guide groove 56 in cooperation with the shuttle guide mainbody 52 to guide the shuttle 26 in the circumferential direction. Thisconfiguration can maintain the shape of the loop LP formed on the needle30 so that the loop LP is not interfered with by other members and doesnot get in the way of other members.

In the suturing device 10 of the present embodiment, the cylindricalmember 12 has a needle guide groove 40. The needle guide groove 40 isconfigured to guide the needle 30 in the longitudinal direction of thecylindrical member 12. Accordingly, the needle 30 can be reciprocatedalong the path K while being guided by the needle guide groove 40,thereby fixing the position of the needle 30 with respect to thethickness direction of the wall of the biological tissue T received inthe depression 34. In this way, a stitch can be obtained by passing thefirst thread-like member L1 through the biological tissue T at a fixedposition in the thickness direction of the wall of the biological tissueT.

The suturing device 10 according to the present embodiment furtherincludes a friction member 42. The friction member 42 is disposed in theneedle guide groove 40 and contactable with the needle 30. Throughcontact with the friction member 42, the first thread-like member L1 ledout from the distal end of the needle 30 forms a loop LP on the distalend of the needle 30 when the needle 30 is retracted.

The suturing device 10 according to the present embodiment furtherincludes a hook member 28. The hook member 28 is positioned in thecylindrical member 12 and is movable in the longitudinal direction ofthe cylindrical member 12. Both of the first thread-like member L1 andthe second thread-like member L2 are parts of a single thread-likemember L. The hook member 28 is configured to hook a first portion L1 ofthe single thread-like member L positioned between the needle 30 and theshuttle 26. Therefore, the formation of a plurality of stitches N iscompleted by forming a knot M after the last stitch N, without requiringformation of a knot M prior to the initial stitch N. Further, byretracting the hook member 28 while the hook member 28 is hooked arounda second portion L2 of the thread-like member L between the needle 30and the shuttle 26, the shuttle 26 can be passed through the loop LPwithout interference from the thread-like member L.

The suturing device 10 according to the present embodiment furtherincludes: a second operating shaft 22; and a third operating shaft 24.The second operating shaft 22 is connected to the needle 30. The secondoperating shaft is configured to reciprocally move the needle 30 in thelongitudinal direction of the cylindrical member 12 and to rotate theneedle 30 about an axis of the needle 30. The third operating shaft 24is connected to the hook member 28. The third operating shaft 24 isconfigured to reciprocally move the hook member 28 in the longitudinaldirection of the cylindrical member 12 and to rotate the hook member 28about an axis of the hook member 28. Therefore, the needle 30 can bereciprocated along the path K by operating the second operating shaft 22so that the second operating shaft 22 is reciprocated along thelongitudinal direction of the cylindrical member 12. Further, the firstthread-like member L1 can be wrapped around the needle 30 by operatingthe second operating shaft 22 so that the second operating shaft 22rotates the needle 30 about its axis. A loop LP is formed on the needle30 by operating the second operating shaft 22 so that the needle 30around which the first thread-like member L1 is wound moves toward theretracted side. Further, by rotating the third operating shaft 24 inorder to rotate the hook member 28, the hook member 28 can be detachedfrom the second thread-like member L2 held in the holding part 62 of theshuttle 26, and by operating the third operating shaft 24 in thelongitudinal direction of the cylindrical member 12 so as to move thehook member 28 in the retracting direction, slack can be formed in thesecond thread-like member L2 held in the holding part 62 of the shuttle26. These operations can prevent the second thread-like member L2 frombecoming entangled when the shuttle 26 is threaded through the loop LP.Further, the hook member 28 can be rotated and detached from the secondthread-like member L2 when the shuttle 26 is moved in the retractingdirection by the first operating shaft 20. Further, slack can once againbe formed in the second thread-like member L2 by first moving theshuttle 26 in the advancing direction through the first operating shaft20 and subsequently rotating the hook member 28 to hook the secondthread-like member L2 that has been passed through the loop LP.

The suturing device 10 according to the present embodiment furtherincludes a suturing target clamping mechanism 78. The suturing targetclamping mechanism 78 is configured to place a biological tissue T incontact with the depression 34 and to immobilize the biological tissue Trelative to the cylindrical member 12. Using the suturing targetclamping mechanism 78 to immobilize the biological tissue T in contactwith the depression 34 reduces any shifting of the biological tissue Tduring suturing, thereby improving the quality of sutures formed in thebiological tissue T. Further, since the suturing target clampingmechanism 78 is configured of a balloon (expanding bag) 78 a provided onthe rear surface of the cylindrical member 12 at a positioncorresponding to the region in which the depression 34 is formed, thebiological tissue T can be fixed in the depression 34 through a simpleconstruction.

In the suturing device 10 of the present embodiment, the needle 30 isconstituted by a tubule. The tubule has an opening 68 positioned at thedistal end portion of the tubule. The first thread-like member passesthrough the tubule and is exposed to an outside of the needle 30 throughthe opening 68. Accordingly, by passing the first thread-like member L1through both the needle 30 and the biological tissue T, the firstthread-like member L1 is exposed outside the biological tissue T at aposition on the advanced side of the path K for the needle 30.

In the suturing device 10 of the present embodiment, the needle isconstituted by a tubule, such as a needle 130 or needle 230. The needle130/230 has an opening 70/72 positioned at a peripheral wall of theneedle 130, 230. The first thread-like member L1 passing through theneedle 130, 230 and is exposed to an outside of the needle 130, 230through the opening 70, 72. Accordingly, by passing the firstthread-like member L1 through both the needle 130/230 and the biologicaltissue T, the first thread-like member L1 is exposed outside thebiological tissue T at a position on the advanced side of the path K forthe needle 130/230.

While the description has been made in detail with reference to specificembodiments thereof, it would be apparent to those skilled in the artthat many modifications and variations may be made thereto.

For example, the first thread-like member L1 and second thread-likemember L2 in the embodiment described above may be any of various suturematerials that can be tied, and preferably natural sutures formed bybraiding natural plant-based or animal-based fibers, polymer suturesformed of monofilament or braided strands of synthetic fibers, metallicsutures formed of monofilament or braided metallic strands, or compositesutures formed of natural and synthetic fibers.

While the needle 30 is rotated only one time in the first stage forforming the knots M1 and M2 in the present embodiment described above inorder to wrap the first thread-like member L1 around the needle 30, theneedle 30 may instead by rotated two or more times. This action canachieve a more secure knot.

Similarly, while the shuttle 26 is passed only one time through the loopLP formed on the needle 30 with the first thread-like member L1 whenforming the knots M1 and M2 in the present embodiment described above,the shuttle 26 instead may be passed two or more times through the loopLP. This method can form an even more secure knot.

In the embodiment described above, the cylindrical member 12 is used asthe casing having an elongated shape, but the member used as the casingmay be another type of cylindrical member, such as a square cylindermember having a polygonal shaped cross section or an elliptic cylindermember having an elliptical cross section.

In the embodiment described above, the first operating handle 21, secondoperating handle 23, and third operating handle 25 are provided forperforming manual operations to advance, retract, or rotate the firstoperating shaft 20, second operating shaft 22, and third operating shaft24. However, in order to perform these operations automatically,electric motors, hydraulic cylinders, and other actuators may beprovided for the first operating shaft 20, second operating shaft 22,and third operating shaft 24. The drive of the actuators may becontrolled according to pre-stored programs to achieve the operationsdescribed in FIGS. 34, 47, and 48, for example.

In the embodiment described above, the knot M is formed after forming aplurality of stitches N, but formation of this knot M is not required.

When forming a stitch N in the embodiment described above, the needle 30is advanced without rotating and retracted to form the loop LP throughwhich the shuttle 26 is passed, but the shuttle 26 may be passed throughthe loop LP formed by retracting the needle 30 after the needle 30 hasbeen advanced with rotation. In this case, the first thread-like memberL1 (bobbin thread (lower thread)) in FIG. 52 is crossed inside thebiological tissue T. This is advantageous in that each stitch N forms aknot.

The depression 34 in the embodiment described above is formed in thecircumferential wall 32 of the cylindrical member 12 functioning as thecasing and is provided with an opening 34 d that is open in the outerwall surface of the circumferential wall 32 of the cylindrical member12. However, the casing may include a base part, a support columnerected from the base part, and an arm part supported on the supportcolumn so as to be parallel to the base part, for example. When theneedle is reciprocated along a path between the base part and the armpart, the base part and the space surrounded by the base part, supportcolumn, and arm part function as the depression. This type of depressionis not provided with what was termed an opening in the embodiment.

In the embodiment described above, the shuttle 26 integrally configuredof the holding part 62 holding the second thread-like member L2 and thefirst and second hook-shaped ends 64 and 66 is threaded through the loopLP, but the shuttle 26 need not pass through the loop LP. For example,the first and second hook-shaped ends 64 and 66 may be configuredseparately from the holding part 62, and the holding part 62 alone maybe passed through the loop LP.

In the embodiment described above, the shuttle guide groove 56 having aconcave cross section is provided in the shuttle guide member 36 forguiding the shuttle 26 in the longitudinal direction of the shuttle 26,i.e., in a circumferential direction around the center axis C1. However,the shuttle guide groove 56 need not have a concave cross section, butmay have another shape capable of guiding the shuttle 26 along itslongitudinal direction. For example, the shuttle guide groove 56 may beconfigured of a convex guide rail, peripheral walls, or the like, aslong as the guide portion can guide the shuttle 26 along itslongitudinal direction.

Although other examples of the description will not be illustratedherein, the description can be implemented in variously modified orrefined forms based on the knowledge of those skilled in the art.

What is claimed is:
 1. A suturing device comprising: a casing having an elongated shape extending in a longitudinal direction; a needle positioned in the casing and having an elongated shape extending in the longitudinal direction, the needle being configured to hold a first thread-like member and to reciprocally move forward and backward in the longitudinal direction to form a loop in the first thread-like member, the needle having a tip end reciprocally moving along a path extending between a first position and a second position in the longitudinal direction in the reciprocal movement of the needle in the longitudinal direction, the first position being positioned forward than the second position in the longitudinal direction; a depression formed in a peripheral wall of the casing and positioned between the first position and the second position in the longitudinal direction, the depression being configured to expose the needle to an outside of the casing; and a shuttle including a holding portion configured to hold a second thread-like member, the shuttle being configured to move within the casing at a third position between the first position and the depression in the longitudinal direction to change relative position between the second thread-like member and the loop.
 2. The suturing device according to claim 1, wherein the depression has a first dimension in the longitudinal direction and a second dimension in a depthwise direction, the second dimension being smaller than the first dimension.
 3. The suturing device according to claim 1, wherein the needle provides a stroke length in the longitudinal direction, and wherein the depression has a dimension in the longitudinal direction, the stroke length being greater than the dimension of the depression.
 4. The suturing device according to claim 1, wherein the casing comprises a hollow cylindrical member.
 5. The suturing device according to claim 1, wherein the needle is configured to permit the first thread-like member extending from the tip end to be shaped into the loop when the tip end moves backward along the path in the longitudinal direction.
 6. The suturing device according to claim 1, wherein the shuttle has one end portion provided with a first hook-shaped portion configured to acquire the loop, the first hook-shaped portion being configured to permit the second thread-like member to pass through the loop.
 7. The suturing device according to claim 6, wherein the shuttle has another end portion provided with a second hook-shaped portion configured to acquire the loop, the second hook-shaped portion being configured to permit the second thread-like member to pass through the loop, the first hook-shaped portion and the second hook-shaped portion being positioned opposite to each other with respect to the holding portion.
 8. The suturing device according to claim 7, wherein the first hook-shaped portion has a first end with an acutely angled tip, the first hook-shaped portion tapering away from the holding portion toward the first end, and wherein the second hook-shaped portion has a second end with an acutely angled tip, the second hook-shaped portion tapering away from the holding portion toward the second end.
 9. The suturing device according to claim 7, further comprising: a shuttle guide member fitted within the casing and having a cylindrical shape extending in the longitudinal direction and providing a circumferential direction, the casing having a center axis extending in the longitudinal direction, the shuttle guide member being movable relative to the casing along the center axis and non-rotatable relative to the casing about the center axis, the shuttle guide member including a guide portion formed into an annular shape, the guide portion being configured to guide the shuttle in the circumferential direction; and a shuttle operating shaft having an end portion connected to the shuttle guide member such that the end portion is immovable relative to the shuttle guide member along the center axis and rotatable relative to the shuttle guide member about the center axis, wherein rotation of the shuttle operating shaft in a first rotating direction about the center axis permits the shuttle to pass through the loop such that the first hook-shaped portion is a leading end in the movement of the shuttle within the casing at the third position, and rotation of the shuttle operating shaft in a second rotating direction opposite to the first rotating direction about the center axis permits the shuttle to pass through the loop such that the second hook-shaped portion is a leading end in the movement of the shuttle within the casing at the third position.
 10. The suturing device according to claim 1, further comprising: a shuttle guide member fitted within the casing and having a cylindrical shape extending in the longitudinal direction and providing a circumferential direction, the casing having a center axis extending in the longitudinal direction, the shuttle guide member being movable relative to the casing along the center axis and non-rotatable relative to the casing about the center axis, the shuttle guide member including a guide portion formed into an annular shape, the guide portion being configured to guide the shuttle in the circumferential direction; and an operating shaft having an end portion connected to the shuttle guide member such that the end portion is immovable relative to the shuttle guide member along the center axis and rotatable relative to the shuttle guide member about the center axis.
 11. The suturing device according to claim 9, further comprising a pusher fixed to the end portion of the shuttle operating shaft, the pusher being configured to abut against one of the one end portion and the another end portion of the shuttle to move the shuttle along the guide portion.
 12. The suturing device according to claim 11, wherein the pusher has an arcuate shape with a circumferential length corresponding to an angle less than 180 degrees whose vertex is the center axis.
 13. The suturing device according to claim 11, wherein the shuttle and the pusher are spaced away from each other in the circumferential direction.
 14. The suturing device according to claim 9, wherein the shuttle has an arcuate shape with a circumferential length corresponding to an angle less than 180 degrees whose vertex is the center axis.
 15. The suturing device according to claim 9, wherein the shuttle guide member has a space extending in the longitudinal direction and in communication with the guide portion, the space being configured to accommodate therein the first thread-like member positioned on the path.
 16. The suturing device according to claim 15, wherein the shuttle guide member comprises: a main body having a cylindrical shape extending in the longitudinal direction and reciprocally movable relative to the casing in the longitudinal direction, the end portion of the first operating shaft penetrating through the main body; and a head fixed to the main body and having a shortened cylindrical shape extending in the longitudinal direction, the head forming the guide portion in cooperation with the main body to guide the shuttle in the circumferential direction.
 17. The suturing device according to claim 1, wherein the casing has a guide groove configured to guide the needle in the longitudinal direction.
 18. The suturing device according to claim 17, further comprising a friction member disposed in the guide groove and contactable with the needle.
 19. The suturing device according to claim 1, further comprising a hook member positioned in the casing and movable in the longitudinal direction, wherein both of the first thread-like member and the second thread-like member are parts of a single thread-like member, the hook member being configured to hook a part of the single thread-like member positioned between the needle and the shuttle.
 20. The suturing device according to claim 19, further comprising: a needle operating shaft connected to the needle, the needle operating shaft being configured to reciprocally move the needle in the longitudinal direction and to rotate the needle about an axis of the needle; and a hook operating shaft connected to the hook member, the hook operating shaft being configured to reciprocally move the hook member in the longitudinal direction and to rotate the hook member about an axis of the hook member.
 21. The suturing device according to claim 1, further comprising a clamping mechanism configured to place a suturing target in contact with the depression and to immobilize the suturing target relative to the casing.
 22. The suturing device according to claim 1, wherein the needle is constituted by a tubule having an opening positioned at a tip end portion of the tubule, the first thread-like member passing through the tubule and being exposed to an outside of the needle through the opening.
 23. The suturing device according to claim 1, wherein the needle is constituted by a tubule having an opening positioned at a peripheral wall of the tubule, the first thread-like member passing through the tubule and being exposed to an outside of the needle through the opening. 